Hepatitis is a disease of the liver, which is usually caused by viral infections. A significant number of patients suffering from hepatitis are infected with either hepatitis B virus (HBV) or hepatitis C virus (HCV). HCV is an RNA virus with a virion size of 30-60 nm. HBV is a DNA virus with a virion size of 42 nm (D. S. Chen, J. Formos. Med. Assoc., 95(1):6-12 (1996)). Serious complications of hepatitis can include cirrhosis, hepatic failure, liver cancer and death.
Nearly 4 million people in the United States and 100 million worldwide are infected with the hepatitis C virus (Alter, M. J., Hepatology, 26(1):625-655 (1997)). In fact, chronic hepatitis C is the most common cause of chronic liver disease and is the leading indication for liver transplantation in the United States (Detre, et al., Viral Hepatitis Rev., 2:219-228 (1996)).
Egypt, where 14-24% of blood donors are anti-HCV positive, has the highest HCV donor infection rates (Hipps, et al., Infect. Dis. 168:789-790 (1993)).
Hepatitis B is a major health problem worldwide, particularly in Asia and Africa. Approximately 300 million people are chronically infected with HBV worldwide and more than one million carriers of HBV are found in the United States. HBV carriers not only become long-term reservoirs of the virus, but also may develop chronic liver disease and have a greatly increased risk of developing liver cirrhosis and cancer.
Unfortunately, there are few effective treatments for hepatitis. Treatment of HCV with recombinant-alpha interferon has a limited long term efficacy with a response rate of only about 25% (D. S. Chen, J. Formos. Med. Assoc., 95(1):6-12 (1996)). A long-term relapse rate of 24% was reported in Chinese patients with chronic hepatitis B who underwent interferon therapy (Lok, et al., Gastroenterology, 105(6):1833-1838 (1993)). Furthermore, interferon is associated with a number of adverse side effects, including thrombocytopenia, leucopenia, bacterial infections, and influenza like symptoms. Other agents used in the treatment of hepatitis include the nucleoside analog ribavirin and ursodeoxycholic acid. However, neither interferon nor ribavirin have been shown to be particularly effective (D. C. Dale and D. D. Federman, eds. Medicine Sc. Amer., Inc., New York, 4(8):1-8 (1995)).
The use of herbal therapy and folk medicines has been known for thousands of years in China. In fact, records on the use of herbs date back to Biblical times. However, only recently have scientists begun exploring the possible role for herbs in treatment of viral infections. For example, extracts of Hemidesmus indicus rhizomes (Family: Asclepiadaceae) have been found to have anti-viral activity against DNA and RNA viruses (Babbar, et al., Ind. J Exp. Biol., 8:304-312 (1970)). Likewise, extracts from the root of the Ecballium elaterium have been used to treat HCV and HBV (EP 0793964 and U.S. Pat. No. 5,648,089). While research in the field of herbal medicines has increased, much remains to be learned about the effectiveness of such herbal remedies.
In view of the above, there is a continuing need in the art for alternative options for treating viral infections such as HCV and HBV. Moreover, there is a need in the art for treatment options that provide minimal side effects.
Accordingly, it is an object of the present invention to provide herbal compositions and methods for treating viral infections such as HCV and HBV. Moreover, it is object of the present invention to provide compositions and methods for treatment that provide minimal side effects to the subject.